The purpose of the NIDCD Research Dissertation Fellowship
for Au.D. Audiologists (F32) program is to support a comprehensive, rigorous
biomedical research training, and dissertation research leading to a research
doctorate (i.e., Ph.D.) in the biomedical, behavioral, or clinical sciences.

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and
Department of Health and Human Services partners. You must use one of these submission
options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online.

The overall goal of the NIH
Ruth L. Kirschstein National Research Service Award (NRSA) program is to help ensure that a diverse pool of highly
trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and
clinical research needs. NRSA fellowships support the training of pre-and
postdoctoral scientists, dual-degree investigators, and senior researchers. More information about NRSA programs may be found
at the Ruth L.
Kirschstein National Research Service Award (NRSA) website.

Research on the measurement of hearing, the clinical
assessment of hearing and balance disorders, and the nonmedical
habilitation/rehabilitation of hearing is uniquely within the area of the
discipline of audiology and NIDCD. In the 1990s the profession of audiology
underwent a major transition in the United States with the introduction of the
professional doctorate, the Au.D. degree, as the standard educational track for
the training of clinical audiologists. However, few Au.D. academic programs
nationwide provide in-depth research-training in audiologic research. Yet, it
is widely recognized that a vibrant research base is imperative for the field
to advance the current state of hearing health care services. Thus, NIDCD
strongly encourages doctoral-level Au.D. audiologists who show promise as
productive researchers to integrate clinical research and translational research
into their career paths. The NIDCD Research Dissertation Fellowship for Au.D. Audiologists
(F32) program aims to support this effort by providing audiologist holding a
Au.D. degree the opportunity to engage in comprehensive rigorous scientific
biomedical research training and complete dissertation research leading to a
research doctorate (i.e., Ph.D.) in the biomedical, behavioral, or clinical
sciences.

The NIDCD Research Dissertation Fellowship for Au.D. Audiologists
(F32) program will enable promising Au.D. holders to obtain individualized,
mentored research training from outstanding faculty sponsors while conducting
dissertation research. Applicants for this F32 program are expected to propose
a dissertation research project and training plan in scientific health-related
fields relevant to the mission of NIDCD. This training plan should reflect the
applicant’s dissertation research project, and facilitate and clearly enhance
the individual’s potential to develop into a productive, independent research
scientist. The training plan should document the need for, and the anticipated
value of, the proposed mentored research and training in relationship to the
individual’s research career goals. The training plan should also facilitate
the fellow’s transition to the next stage of his/her research career.

It is expected that the mentored research training
experience will provide:

A strong foundation in research design, methods, and analytic
techniques appropriate to the proposed dissertation research;

The enhancement of the applicant's ability to conceptualize and
think through research problems with increasing independence;

Experience conducting research using appropriate,
state-of-the-art methods, as well as presenting and publishing the research
findings as first author;

The opportunity to interact with members of the scientific
community at appropriate scientific meetings and workshops;

Skills needed to transition to the next stage of the applicant’s
research career; and

The opportunity to enhance the applicant’s understanding of the
health-related sciences and the relationship of the proposed research to health
and disease.

Applicants for the NIDCD Research Dissertation Fellowship
for Au.D. Audiologists (F32) program must be candidates for the PhD degree and
have identified a dissertation research project and sponsor(s). The program
will provide up to three years of support at the postdoctoral level for
research training which leads to the Ph.D. or equivalent research doctoral
degree in the biomedical, behavioral, or clinical sciences. It will only
support dissertation research training.

The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.

Award Budget

Award budgets are composed of stipends, tuition and fees,
and institutional allowance, as described below.

Award Project Period

Individuals may receive up to 5 years of aggregate
Kirschstein-NRSA support at the predoctoral level (up to 6 years for dual
degree training, e.g., MD/PhD), and up to 3 years of aggregate
Kirschstein-NRSA support at the postdoctoral level, including any combination
of support from institutional training grants (e.g., T32) and an individual
fellowship award.

Stipend levels, as well as funding amounts for tuition and
fees and the institutional allowance are announced annually in the NIH Guide
for Grants and Contracts, and are also posted on the Ruth L. Kirschstein
National Research Service Award (NRSA) webpage.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Before submitting a
fellowship application, the applicant must identify a sponsoring institution.
The sponsoring institution must have staff and facilities available on site to
provide a suitable environment for performing high-quality research training.
The training should occur in an environment that has appropriate human and
technical resources and is demonstrably committed to training in the field(s)
proposed by the applicant. The sponsoring institution may be private (profit or
nonprofit) or public, including the NIH Intramural Programs and other Federal
laboratories.

An individual may request support for training abroad. In
such cases, the applicant is required to provide detailed justification for the
foreign training, including the reasons why the facilities, the sponsor, and/or
other aspects of the proposed experience are more appropriate than training in
a domestic setting. The justification is evaluated in terms of the scientific
advantages of the foreign training as compared to the training available
domestically. Foreign training will be considered for funding only when the scientific
advantages are clear.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to
apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant
Organizations

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants must have an active DUNS number and SAM registration in order to
complete the eRA Commons registration. Organizations can register with the eRA
Commons as they are working through their SAM or Grants.gov registration. eRA
Commons requires organizations to identify at least one Signing Official (SO)
and at least one Program Director/Principal Investigator (PD/PI) account in
order to submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons.If the PD/PI is also the organizational Signing
Official, they must have two distinct eRA Commons accounts, one for each role.
Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any applicant fellow with the skills, knowledge, and
resources necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her sponsor and organization
to develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a
non-citizen national of the United States or have been lawfully admitted for
permanent residence (i.e., possess a currently valid Permanent Resident Card
USCIS Form I-551, or other legal verification of such status).

The applicant must be at the dissertation research stage of
training at the time of award and must show evidence of high academic
performance in the sciences, and commitment to a career as an independent
research scientist.

The applicant must be currently enrolled in a PhD or
equivalent research degree program (e.g., EngD, DNSc, DrPH, DSW, PharmD, ScD)
in the biomedical, behavioral, or clinical sciences at a domestic or foreign
institution.

Before a Kirschstein-NRSA NIDCD Research Dissertation Fellowship for Au.D. Audiologists (F32) award can
be activated, the individual must have received an Au.D. doctoral degree from an accredited domestic or
foreign institution and been admitted to candidacy for the Ph.D. at the
applicant institution..

The NIH will not accept duplicate or highly overlapping
applications under review at the same time. This means that the NIH will
not accept:

A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.

A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another
application pending appeal of initial peer review (see NOT-OD-11-101).

Duration of Support

Individuals may not exceed the aggregate limit of NRSA
support shown above in the Award Project Period (see Section II. Award Information). Applicant fellows must consider
any prior NRSA research training in determining the duration of support
requested. Information regarding previous Kirschstein-NRSA support must be
included in the application and will be considered at the time of award.

Level of Effort

At the time of award, individuals are required to pursue
their research training on a full-time basis, normally defined as 40 hours per
week or as specified by the sponsoring institution in accordance with its own
policies.

Sponsor

Before submitting the
application, the applicant must identify a sponsor(s) who will supervise the
proposed mentored training experience. The primary sponsor should be an active
investigator in the area of the proposed research training and be committed
both to the applicant’s research training and to direct supervision of his/her
research. The sponsor must document the availability of sufficient research
funds and facilities for high-quality research training. The sponsor, or a
member of the sponsor team, should have a successful mentorship record. Applicants are encouraged to identify
more than one sponsor, i.e., a sponsor team, if this is deemed advantageous for
providing expert advice in all aspects of the training program. When there is a
sponsor team, one individual must be identified as the primary sponsor, and
will be expected to coordinate the applicant’s overall training. The applicant
must work with the sponsor(s) in preparing the application.

Section IV. Application
and Submission Information

1. Requesting an
Application Package

Applicants must obtain the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, including Supplemental
Grant Application Instructions except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the SF424 (R&R)
Application Guide and the Table of
Page Limits must be followed.

Instructions
for Application Submission

The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

Other Project InformationAll instructions in
the SF424 (R&R) Application Guide must be followed, with the following
additional instructions:

Other
Attachments: The following additional educational information
is required and should be attached under Other Attachments:

Describe the graduate program in which the applicant is enrolled,
e.g. the structure of the program, required milestones and their usual timing
(number of courses, any teaching commitments, qualifying exams, etc.), and the
average time to degree over the past 10 years. Describe the progress/status of
the applicant in relation to the program’s time line. Describe the frequency
and method by which the program formally monitors and evaluates a student’s
progress. This information is typically provided by the director of the
graduate program or the department chair. Include the name of the individual
providing this information at the end of the description.

Note that a listing of the applicant’s courses and grades must be
included in the Fellowship Applicant Biographical Sketch, and NOT in this
attachment.

Please name this attachment “Additional Educational Information.”

The filename provided for each “Other Attachment” will be
the name used for the bookmark in the electronic application in eRA Commons.

SF424(R&R) Senior/Key Person Profile Expanded

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS Fellowship Supplemental Form

The PHS Fellowship Supplemental Form is comprised of the
following sections:

Fellowship Applicant

Research Training Plan

Sponsor(s), Collaborator(s), and Consultant(s);

Institutional Environment & Commitment to Training

Other Research Training Plan Sections

Additional Information

Budget

Appendix

All instructions in the SF424 (R&R) Application Guide
must be followed.

Appendix

Do not use the Appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions
for completing PHS Inclusion Enrollment Report as described in the SF424
(R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

For FOAs that do not allow independent clinical trials, do not complete Section 4 - Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments.

Delayed Onset StudyAll instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must
be followed.

Letters of Reference

Applicants must carefully
follow the SF424 (R&R) Application Guide, including the time period for when
letters of reference will be accepted. Applications lacking the appropriate required reference letters will
not be reviewed. This is a separate process from submitting an application
electronically. Reference letters are submitted directly through the eRA Commons Submit Reference Letter link and not through Grants.gov.

Foreign Institutions

Foreign (non-U.S.) Institutions must follow policies
described in the NIH Grants
Policy Statement, and procedures for foreign institutions described
throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award
Management (SAM)

See Part 1. Section III.1 for information regarding the
requirement for obtaining a unique entity identifier and for completing and
maintaining active registrations in System for Award Management (SAM), NATO
Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and
Grants.gov.

4. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to
submit applications before the due date to ensure they have time to make any
application corrections that might be necessary for successful submission. When
a submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next
business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the
application due date and time. If a Changed/Corrected application is submitted
after the deadline, the application will be considered late. Add
Applications that miss the due date and time are subjected to the NIH Policy on
Late Application Submission.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants
Policy Statement. The National
Research Service Award (NRSA) policies apply to this program. A
Kirschstein-NRSA fellowship may not be held concurrently with another federally
sponsored fellowship or similar Federal award that provides a stipend or
otherwise duplicates provisions of this award.

Pre-award costs are generally not allowable for Fellowships.

7. Other Submission
Requirements and Information

Applications must be submitted electronically following the
instructions described in the SF424 (R&R) Application Guide. Paper
applications will not be accepted.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must
follow the Guidelines
for Applicants Experiencing System Issues. For assistance with application
submission, contact the Application Submission Contacts in Section VII.

Important
reminders:All PD(s)/PI(s) and sponsor(s) must include their eRA Commons
ID in the Credential fieldof the Senior/Key Person Profile Component of
the SF424(R&R) Application Package. Failure to register in the
Commons and to include a valid PD/PI Commons ID in the credential field will
prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness and compliance with application instructions by the Center for
Scientific Review, NIH. Applications that are incomplete or non-compliant will
not be reviewed.

Post Submission Materials

Applicants are required to follow our Post Submission Application Materials policy.
Because the Sponsor(s)’ funding is an important factor in the review of a
Fellowship application, post-submission material that updates the Sponsor(s)’
funding information in the originally submitted application is allowed.
Information on the Sponsor(s)’ funding information must not exceed 1 page, and
is limited to the project title, funding source (e,g. NIH grant number), and a
brief description of the Specific Aims and relevance to the fellowship
application under review. The additional material is due no later than 30 days
prior to the meeting of the review committee. See also: NOT-OD-12-022.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

For this particular announcement, note the following:

A fellowship application has a research project that is
integrated with the training plan. The review will emphasize the applicant’s
potential for a productive career, the applicant’s need for the proposed
training, and the degree to which the research project and training plan, the
sponsor(s), and the environment will satisfy those needs.

Overall Impact/Merit

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood that the fellowship will enhance the applicant’s
potential for, and commitment to, a productive independent scientific research
career in a health-related field, in consideration of the scored and additional
review criteria.

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact.

Fellowship
Applicant

Are the applicant’s academic record and research experience of
high quality?

Does the applicant have the potential to develop into an
independent and productive researcher?

Does the applicant demonstrate commitment to a research career in
the future?

Sponsors,
Collaborators, and Consultants

Are the sponsor(s’) research qualifications (including recent
publications) and mentorship record at a similar stage appropriate for the
needs of the applicant?

Is there evidence of a match between the research and clinical
interests (if applicable) of the applicant and the sponsor(s)? Do(es) the
sponsor(s) demonstrate an understanding of the applicant’s training needs as
well as the ability and commitment to assist in meeting these needs?

Is there evidence of adequate research funds to support the
applicant’s proposed research project and training for the duration of the
research component of the fellowship?

If a team of sponsors is proposed, is the team structure well
justified for the mentored training plan, and are the roles of the individual
members appropriate and clearly defined?

Are the qualifications of any collaborator(s) and/or
consultant(s), including their complementary expertise and previous experience
in fostering the training of fellows, appropriate for the proposed project?

Research
Training Plan

Is the proposed research project of high scientific quality, and
is it well integrated with the proposed research training plan?

Based on the sponsor’s description of his/her active research
program, is the applicant’s proposed research project sufficiently distinct
from the sponsor’s funded research for the applicant’s career stage?

Is the research project consistent with the applicant’s stage of
research development?

Is the proposed time frame feasible to accomplish the proposed
training?

Training
Potential

Are the proposed research project and training plan likely to
provide the applicant with the requisite individualized and mentored
experiences in order to obtain appropriate skills for a research career?

Does the training plan take advantage of the applicant’s
strengths and address gaps in needed skills? Does the training plan document a
clear need for, and value of, the proposed training?

Does the proposed training have the potential to serve as a sound
foundation that will clearly enhance the applicant’s ability to develop into a
productive researcher?

Institutional Environment
& Commitment to Training

Are the research facilities, resources (e.g., equipment,
laboratory space, computer time, subject populations), and training
opportunities (e.g. seminars, workshops, professional development
opportunities) adequate and appropriate?

Is the institutional environment for the applicant’s scientific
development of high quality?

Is there appropriate institutional commitment to fostering the
applicant’s mentored training.

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for
Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For additional
information on review of the Human Subjects section, please refer to the Guidelines
for the Review of Human Subjects.

Inclusion of
Women, Minorities, and Children

When the proposed project involves
human subjects and/or NIH-defined clinical research, the committee will
evaluate the proposed plans for the inclusion (or exclusion) of individuals on
the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion)
of children to determine if it is justified in terms of the scientific goals
and research strategy proposed. For additional information on review of the
Inclusion section, please refer to the Guidelines
for the Review of Inclusion in Clinical Research.

Vertebrate
Animals

The committee will evaluate the
involvement of live vertebrate animals as part of the scientific assessment
according to the following criteria: (1) description of proposed procedures
involving animals, including species, strains, ages, sex, and total number to
be used; (2) justifications for the use of animals versus alternative models
and for the appropriateness of the species proposed; (3) interventions to
minimize discomfort, distress, pain and injury; and (4) justification for
euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia
of Animals. Reviewers will assess the use of chimpanzees as they would any
other application proposing the use of vertebrate animals. For additional
information on review of the Vertebrate Animals section, please refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

Not Allowed

Revisions

Not Allowed

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Training in the
Responsible Conduct of Research

All applications
for support under this FOA must include a plan to fulfill NIH requirements for
Instruction in the Responsible Conduct of Research (RCR). Taking into
account the level of experience of the applicant, including any prior
instruction or participation in RCR as appropriate for the applicant’s career
stage, the reviewers will evaluate the adequacy of the proposed RCR training in
relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework,
and/or real-time discussion groups (a plan with only on-line instruction is not
acceptable); 2) Subject Matter - the breadth of subject matter,
e.g., conflict of interest, authorship, data management, human subjects and
animal use, laboratory safety, research misconduct, research ethics; 3) Faculty
Participation - the role of the sponsor(s) and other faculty
involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are
required); and 5) Frequency of Instruction – instruction must
occur during each career stage and at least once every four years. Plans
and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and
the summary statement will provide the consensus of the review committee. See
also: NOT-OD-10-019.

Applications from
Foreign Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agent
Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), convened by NIDCD in
accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a committee process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications . Following
initial peer review, recommended applications will receive a second level of
review by the appropriate NIH Institute or Center. The following will be
considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and
conditions found on the Award
Conditions and Information for NIH Grants website. This includes any
recent legislation and policy applicable to awards that is highlighted on this
website.

Recipients of federal financial
assistance (FFA) from HHS must administer their programs in compliance with
federal civil rights law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person’s race, color,
national origin, disability, age and, in some circumstances, sex and religion.
This includes ensuring your programs are accessible to persons with limited
English proficiency. HHS recognizes that research projects are often limited
in scope for many reasons that are nondiscriminatory, such as the principal
investigator’s scientific interest, funding limitations, recruitment
requirements, and other considerations. Thus, criteria in research protocols
that target or exclude certain populations are warranted where
nondiscriminatory justifications establish that such criteria are appropriate
with respect to the health or safety of the subjects, the scientific study
design, or the purpose of the research.

For additional guidance regarding how the provisions apply
to NIH grant programs, please contact the Scientific/Research Contact that is
identified in Section VII under Agency Contacts of this FOA. HHS provides
general guidance to recipients of FFA on meeting their legal obligation to take
reasonable steps to provide meaningful access to their programs by persons with
limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html.
The HHS Office for Civil Rights also provides guidance on complying with civil
rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html;
and http://www.hhs.gov/ocr/civilrights/understanding/index.html.
Recipients of FFA also have specific legal obligations for serving qualified
individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
Please contact the HHS Office for Civil Rights for more information about
obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS
Departmental goal to ensure access to quality, culturally competent care,
including long-term services and supports, for vulnerable populations. For
further guidance on providing culturally and linguistically appropriate
services, recipients should review the National Standards for Culturally and
Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

As specified in the NIH Revitalization Act of 1993,
Kirschstein-NRSA recipients incur a service payback obligation for the first 12
months of postdoctoral support. Policies regarding the Kirschstein-NRSA payback
obligation are explained in the NIH Grants
Policy Statement; applicants may also wish to review Frequently
Asked Questions for more details. The taxability of stipends is described
in the NIH
Grants Policy Statement.

Inventions and Copyrights

Fellowships funded primarily for educational purposes are
exempted from the PHS invention requirements and thus invention reporting is
not required. More details, including exceptions for fellows training at NIH
are provided in the NIH Grants
Policy Statement.

3. Reporting

When multiple years are involved, awardees will be required
to submit the Research
Performance Progress Report (RPPR) annually. The report is due two months
before the beginning date of the next budget period and must include information
describing the current year's progress as well as the research and training
plans for the coming year.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

Other Fellowship Reporting
Requirements:

Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award.

The fellowship award recipient has up to six months from the issue date on the Notice of Award to activate the award using the
Kirschstein-NRSA Individual Fellowship Activation Notice (PHS 416-5). Under unusual circumstances, NIH may grant an extension of the activation period upon receipt of a specific request from the fellow. Such a request must be countersigned by the sponsor and an authorized institutional official.

For the individual's initial 12 months of Kirschstein-NRSA postdoctoral support, a signed, original Payback Agreement Form (PHS 6031) must accompany the Activation Notice.

At the conclusion of a fellowship, the fellow must submit a Termination Notice (PHS 416-7) via xTrain to the NIH within 30 days of termination. Fellows with service payback requirements must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS 6031-1) until the payback service obligation is satisfied.

4. Evaluation

In carrying out its stewardship of human resource-related
programs, the NIH may request information essential to an assessment of the
effectiveness of this program from databases
and from participants themselves. Participants
may be contacted after the completion of this award for periodic updates on
various aspects of their employment history, publications, support from
research grants or contracts, honors and awards, professional activities, and
other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.